EP3824793B1 - Guidewire and catheter system for in-vivo forward viewing of the vasculature - Google Patents
Guidewire and catheter system for in-vivo forward viewing of the vasculature Download PDFInfo
- Publication number
- EP3824793B1 EP3824793B1 EP20209203.7A EP20209203A EP3824793B1 EP 3824793 B1 EP3824793 B1 EP 3824793B1 EP 20209203 A EP20209203 A EP 20209203A EP 3824793 B1 EP3824793 B1 EP 3824793B1
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- EP
- European Patent Office
- Prior art keywords
- lens
- atraumatic
- camera chip
- distal
- guidewire
- Prior art date
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Description
- The present invention relates to the art of delivering medical therapy to a remote site in a body. More particularly, the present invention relates to a video camera equipped guidewire that extends through the lumen of a light-illuminating catheter. The guidewire and catheter are moved through the vasculature together. The catheter has optical fibers that illuminate the path forward through the vasculature while the camera in the catheter sends a video feed back to a controller connected to a video display.
- The current gold standard for imaging during interventional procedures is fluoroscopy. However, fluoroscopy gives 2D greyscale images which require a significant amount of interpretation from the surgeon. This both slows down the procedure and adds to its difficulty. Also, other than giving 2D dimensions, fluoroscopy provides limited information about the diseased area.
- Another problem with fluoroscopy is that it is relatively dangerous. According to the FDA, fluoroscopy can result in relatively high radiation doses, especially for complex interventional procedures such as placing stents or other devices inside the body. These types of interventional procedures require that fluoroscopy be administered for a relatively long period of time. Radiation-related risks associated with fluoroscopy include: radiation-induced injuries to the skin and underlying tissues ("burns"), which occur shortly after the exposure, and radiation-induced cancers, which may occur sometime later in life.
US2015202089 discloses an illumination fiber which extends along the interior of core wire and terminates in an atraumatic lens. - Aspects and embodiments of the invention are set out in the appended claims.
- These and other objects of the present invention will become increasingly more apparent to those skilled in the art by reference to the following detailed description and to the appended drawings.
-
-
FIG. 1 is a schematic view of an exemplary guidewire andcatheter system 10 according to the present disclosure moving through thevasculature 42 of a patient; a visual display of the vasculature is also shown. -
FIG. 2 is a side elevational view of the guidewire andcatheter system 10 shown inFIG. 1 . -
FIG. 3 is a cross-sectional and exploded view of adistal portion 12A of theguidewire 12 shown inFIG. 1 . -
FIG. 4 is a cross-sectional view of aproximal portion 12B of theguidewire 12 shown inFIG. 1 . -
FIG. 5 is a cross-sectional view of theguidewire 12 being electrically connected to theproximal connector 18 shown inFIG. 1 . -
FIG. 6 is a cross-sectional view of theguidewire 12 andproximal connector 18 shown inFIG. 5 being electrically connected. -
FIG. 7A is a cross-sectional view of theatraumatic head 14 for theguidewire 12 showing the paths of various incoming light rays as they travel through thelens 46 before impinging on thecamera chip 16. -
FIG. 7B is a cross-sectional view of anatraumatic head 14A for theguidewire 12 showing the paths of various incoming light rays as they travel through alens 47 and then a disc-shaped void space 96 before impinging on thecamera chip 16. -
FIG. 7C is a cross-sectional view of anatraumatic head 14B for theguidewire 12 showing the paths of various incoming light rays as they travel through alens 47A and then a hemispherical- or parabolic-shaped void space 96A before impinging on thecamera chip 16. -
FIG. 8 is a cross-sectional view showing how an image of a target object/tissue is projected onto acamera chip 16 through thelens 46 shown inFIG. 7B . -
FIGs. 9A and 9B are cross-sectional views illustrating that as the thickness of thevoid space 96 in thelens 47 shown inFIG. 7B changes, that in turn changes the position of a respective proximalfocal point -
FIG. 10 is a cross-sectional view of another embodiment of an atraumatic head 14C having an achromatic lens doublet comprising adistal lens 144 optically connected to aproximal lens 146 to limit the effects of chromatic and spherical aberration. -
FIG. 11 is a cross-sectional view of another embodiment of anatraumatic head 14D showing light rays entering anatraumatic lens 156 optically coupled to a collimatingGRIN lens 166 before reflecting off amirror 164 to then impinge on acamera chip 16. -
FIG. 12 is a cross-sectional view of another embodiment of anatraumatic head 14E that is similar to theatraumatic head 14D shown inFIG. 11 , but with theatraumatic lens 156A having a disc-shaped void space 178. -
FIG. 13 is a cross-sectional view of another embodiment of anatraumatic head 14F showing light rays impinging on a lateralatraumatic lens 190 optically connected to a lateral collimatingGRIN lens 188 with the light rays then being directed to thecamera chip 16. -
FIG. 14 is a cross-sectional view of another embodiment of a hybridatraumatic head 14G which is a combination of theatraumatic heads FIGs. 11 and13 , respectively. -
FIG. 15 is a schematic view of thecatheter 24 for the guidewire andcatheter system 10 shown inFIGs. 1 and2 . - The present disclosure combines a guidewire that is equipped with a video camera in its atraumatic head with a light-illuminating catheter. The catheter has an array of light-emitting lenses connected to optical fibers. With the guidewire residing in the catheter lumen, the atraumatic head of the guidewire is positioned a short distance ahead or distal the light-emitting lenses of the catheter. With the video camera in the atraumatic head of the guidewire sending a real-time video feed of the vasculature back to the surgeon, the surgeon is better able to control the directional movement of the catheter/guidewire system through the vasculature. That is done by manipulating the guidewire using a series of pull-wires so that the catheter is bent into a directional orientation in anticipation of the viewed route of the vasculature immediately ahead. This helps to reduce trauma to the vasculature as there is not as much contact with the vasculature as there might be without video viewing.
- Moreover, once the catheter/guidewire system has reached the body tissue of interest in the vasculature, the video camera enables the surgeon to access the diseased tissue faster and more accurately, which helps the surgeon decide in a treatment protocol faster than when using a system without light-assisted video viewing. Further, once a treatment has been deployed, for example, a stent has been placed in the vasculature to open an occlusion, the catheter/guidewire system of the present disclosure helps in in situ assessment of proper stent placement and treatment efficacy.
- Turning now to the drawings, an exemplary guidewire and
catheter system 10 according to the present disclosure is generally illustrated inFIGs. 1 and2 . Thesystem 10 comprises aguidewire 12 extending along a longitudinal axis A-A from a guidewiredistal portion 12A (FIG. 3 ) to aproximal portion 12A (FIG. 4 ). The guidewiredistal portion 12A has anatraumatic head 14 provided with acamera chip 16. Theguidewire 12 is detachably connectable to aproximal connector 18 powered by acontroller 20 that is wired to avisual display 22. - Separately, a
catheter 24 of thesystem 10 has a cylindrically-shaped sidewall 26 that defines an axially-extendingprimary lumen 28. Thecatheter sidewall 26 supports a number of optical fibers, for example, optical fibers 30, 32 and 34. The optical fibers 30, 32 and 34 are evenly spaced at 120° intervals about theprimary lumen 28 and extend through thesidewall 26 to respective light-emitting lenses lenses vasculature 42 of a patient as the guidewire andcatheter system 10 of the present disclosure is used in a medical procedure. The optical fibers 30, 32 and 34 are optically connected to thecontroller 20 to provide electrical power to the light-emittinglenses - In a preferred embodiment, each optical fiber 30, 32 and 34 in connected to a different wavelength spectrum coming from the
controller 20 to allow multispectral illumination by the respective light-emitting lenses - Referring to
FIGs. 3 to 6 , theguidewire 12 is shown in greater detail aligned along a longitudinal axis A-A and comprising acore wire 44 extending from a core wireproximal portion 44A having aproximal end 44B to a core wiredistal portion 44C having adistal end 44D. A core wireintermediate portion 44E resides between the core wire proximal anddistal portions tapered portion 44F extends downwardly and proximally along the longitudinal axis A-A from theintermediate portion 44E to the core wireproximal portion 44A. Similarly, a distal tapered portion 42G extends downwardly and distally along the longitudinal axis A-A to the core wiredistal portion 44C. Theatraumatic head assembly 14 supporting thecamera chip 16 is connected to the core wiredistal end 44D. - In an alternate embodiment, the
core wire 44 is replaced with a hypotube. -
Figure 3 illustrates thedistal portion 12A of theguidewire 12 and theatraumatic head 14 in greater detail. Theatraumatic head 14 comprises a plano-convexatraumatic lens 46 connected to a medical grade polymeric material or ametal housing 48. If metal, stainless steel is preferred for the housing. Thehousing 48 comprises a cylindrically-shapedproximal section 48A meeting an enlarged diameter cylindrically-shapeddistal section 48B at anannular step 48C. The housingdistal section 48B has anannular rim 48D that surrounds arecess 50. - The
atraumatic lens 46 has aproximal section 46A of a reduced diameter that is sized and shaped to snuggly fit into therecess 50 of thehousing 48. In that manner, the atraumatic lens is supported by the housing. Thelens 46 preferably has a hemispherical- or parabolic-shaped exterior surface so that tissue trauma is minimized as theguidewire 12 moves through the vasculature of a patient. Suitable materials for thelens 46 include optical glasses such as silicon dioxide, fused silica and quartz, zinc selenide, zinc sulfide, germanium, sapphire, calcium fluoride, and barium fluoride. Optical plastics such as optical silicone elastomers, poly methyl methacrylate, polycarbonate, and polystyrene are also suitable materials for thelens 46. - An off-set bore 52 extends through the
housing 48 from aproximal face 48E to therecess 50. A double-sided or multilayer printed circuit board (PCB) 54 is nested in therecess 50. ThePCB 54 mechanically supports thecamera chip 16, which is preferably a CMOS or CCD camera chip, and electrically connect the camera chip to theelectrical cable 56. ThePCB 54 has conductive tracks, pads and other electrical features (not shown) etched from one or more layers of copper laminated onto or between layers of a non-conductive substrate. The CMOS orCCD camera chip 16 is soldered onto or otherwise attached to thePCB 54 to mechanically fasten the two components together and electrically connect the camera chip to theelectrical cable 56. - An
electrical cable 56 extends along agroove 58 in thecore wire 44, through thebore 52 in thehousing 48 to thecamera chip 16 supported on thePCB 54. Thecamera chip 16 is protected from damage during use by a transparentprotective coating 60. - As shown in
FIG. 3 , prior to connecting theatraumatic head 14 to thedistal end 44D of thecore wire 44, adistal coil spring 62 is fitted over thedistal portion 44C of the core wire. A proximal end of thecoil spring 62 is connected to the distal taperedportion 44G of thecore wire 44. At its opposed distal end, thecoil spring 62 is connected to thehousing 48 for the atraumatic head at theannular step 48C. -
Figure 4 is an enlarged view of theproximal portion 12B of theguidewire 12. This drawing shows the proximaltapered portion 44F of thecore wire 44 residing between the core wire proximal andintermediate portions polymeric sleeve 64 is supported on the core wireproximal portion 44A and theproximal taper 44F. Thepolymeric sleeve 64 supports a number of spaced-apart ring-shaped electrical contacts, for example, fourelectrical contacts electrical contacts electrical cable 56 electrically connected to thePCB 54 in thehousing 48 for theatraumatic head 14. -
Figures 5 and 6 illustrate theproximal connector 18 comprising an open-ended housing of an electrically insulative material. The connector housing has anannular sidewall 18A surrounding achannel 68 leading to anend wall 18B. A primaryelectrical cable 74 connecting from the controller 20 (FIG. 1 ) leads to theend wall 18B where the cable splits into insulated electrical wires 74A, 74B, 74C and 74D. Theconnector sidewall 18A supports a number of spaced apart ring-shaped electrical contacts, for example, fourelectrical contacts electrical contacts channel 68 in theproximal connector 18 is sized and shaped to receive theproximal portion 12B of theguidewire 12. With theproximal portion 12B housed inside theconnector channel 68, the ring-shapedelectrical contacts proximal connector 18 are electrically connected to the ring-shapedelectrical contacts guidewire 12. Connecting theguidewire 12 to theproximal connector 18 thereby establishes electrical continuity from thecontroller 20 to thechip camera 16 supported on thePCB 54 in theatraumatic head 14. -
Figure 7A shows one embodiment for theatraumatic head 14 of theguidewire 12 of thepresent system 10. In this drawing the light rays are shown emanating from a distant object (not shown) that is relatively far from thelens 46. In this situation, thelight rays light rays atraumatic lens 46 and theprotective coating 60 to then impinge on thecamera chip 16 with minimal refraction from the longitudinal axis. - Another pair of
light rays light rays lens 46. Thelens 46 causes theselight rays lens 46 to then impinge on the focal plane of the lens below the longitudinal axis where thecamera chip 16 is positioned (the focal plane is aligned along the forward or distal face of the chip 16). Conversely,light rays lens 46 from a distance that is substantially below the path of theaxial light rays lens 46 causes theselight rays lens 46 to then impinge on the focal plane of the lens below that axis. An inverted image of the distant object results from the light ray pairs 98A, 98B and 100A, 100B and 102A and 102B impinging on thecamera chip 16 positioned at the focal plane at different locations along its face. -
Figure 7B shows another embodiment of anatraumatic head 14A according to the present disclosure. Theatraumatic head 14A has alens 47, which has a hemispherical- or parabolic-shaped exterior surface and is made of similar materials as previously described forlens 46, that includes a disc-shapedvoid space 96 immediately adjacent to the transparentprotective coating 60. The benefit of having thevoid space 96 is that it adds a second medium in addition to theatraumatic lens 47 through which light rays must pass before they impinge on the focal plane (the focal plane is aligned along the forward or distal face of the chip 16). That way, thevoid space 96 provides a degree of control over the position of the focal plane of the lens where the distal face of thecamera chip 16 is positioned. - Looking first at
light rays atraumatic lens 47, thevoid space 96 and theprotective coating 60 with minimal refraction to then impinge on the focal plane of the lens where the distal face of thecamera chip 16 is positioned. - The second pair of
light rays light rays atraumatic lens 47, which causes theselight rays void space 96.Light rays void space 96 where they cross the longitudinal axis A-A inside the void space to pass through theprotective coating 60 before impinging on the focal plane of the lens where the distal face of thecamera chip 16 is positioned and below the longitudinal axis. - Conversely,
light rays lens 47 from a distance that is spaced substantially below the axial path oflight rays lens 47 causes theselight rays void space 96 where they refract a second time at a greater acute refraction angle beta "β'" (α' < β') with respect to the axis A-A. In the disc-shapedvoid space 96, thelight rays protective coating 60 before impinging on the focal plane of the lens below the longitudinal axis. The second refraction angles β and β' through the disc-shapedvoid space 96 are intended to cause a greater number of light rays that are incident the outer periphery of theatraumatic lens 47 to ultimately impinge on the thecamera chip 16. An inverted image of the distant object results from thelight rays camera chip 16 at different locations along its face. -
Figure 7C illustrates another embodiment of theatraumatic head 14B where the light rays emanate from a distant object (not shown) that is relatively far from thelens 47A. Thelens 47A is similar to theatraumatic lens 47 shown inFIG. 7B , except that instead of a disc-shapedvoid space 96, there is a hemispherical- or parabolic-shapedvoid space 96A. As with the disc-shapedvoid space 96 shown inFIG. 7B , the hemispherical- or parabolic-shapedvoid space 96A adds a second medium in addition to theatraumatic lens 47A through which the light rays 98A, 98B, 100A, 100B, 102A and 102B must refract before they impinge on the camera chip 16 (the forward or distal face of thechip 16 is aligned along the focal plane). -
Light rays atraumatic lens 47A, thevoid space 96A and theprotective coating 60 to then impinge on thecamera chip 16 at the focal plane of the lens with minimal refraction. - The second pair of
light rays light rays atraumatic lens 47A which causes theselight rays void space 96A.Light rays void space 96A where they cross the longitudinal axis A-A to pass through theprotective coating 60 before impinging on the focal plane of thelens 16 below the longitudinal axis. -
Figure 7C further showslight rays lens 47A from a distance that is spaced substantially laterally below the axial path oflight rays lens 47A causes theselight rays void space 96A where they refract a second time at a greater acute refraction angle beta "β'" (α' < β') with respect to the axis A-A. In the hemispherical- or parabolic-shapedvoid space 96A, thelight rays protective coating 60 before impinging on the focal plane oflens 16 below the longitudinal axis (the forward or distal face of thechip 16 is aligned along the focal plane). The second refraction angles β and β' through the hemispherical- or parabolic-shapedvoid space 96A are intended to cause a greater number of light rays that are incident the outer periphery of the hemispherical- or parabolic-shapedatraumatic lens 47A to ultimately impinge on thecamera chip 16. An inverted image of the distant object results from thelight rays camera chip 16 at different locations along the face of the camera chip. -
Figure 8 shows how an image of the target object/tissue is projected onto thecamera chip 16 by geometrical ray tracing. Afirst ray 104 from the tip of theobject 106 is aligned parallel to the longitudinal axis A-A passing through thelens 47 shown inFIG. 7B and then through a proximalfocal point 108 in the disc-shapedvoid space 96. Asecond ray 110 is shown going from the tip of theobject 106 directly through thelens 47 and disc-shapedvoid space 96 without any refraction. Athird ray 112 from the tip of theobject 106 is shown passing through a distalfocal point 114 and then through thelens 47 where it refracts into the disc-shapedvoid space 96 aligned parallel to the longitudinal axis A-A. In anexemplary guidewire 12 having a diameter of about 0.014" (360 µm), thelens 47 has adiameter 116 of about 360 µm. If the lens has a radius ofcurvature 118 of 180 µm and alens centre thickness 120 of 120 µm, then the distalfocal length 122 is 390 µm from thetangent plane 94 and the proximalfocal point 108 is 270 µm from aproximal surface 124 of the lens. - Continuing from
FIG. 7A where theatraumatic lens 46 does not have a void space in comparison toFIG. 7B where theatraumatic lens 47 has the disc-shapedvoid space 96,FIGs. 9A and 9B illustrate that as the thickness of the void space changes, the thickness of the lens changes which in turn changes the position of the proximal focal point. InFIG. 9A , thelens 126, which has a hemispherical- or parabolic-shaped exterior surface and is made of similar materials as previously described forlens 46, has a disc-shapedvoid space 128 with a thickness (t) aligned along the longitudinal axis A-A as measured fromsurface 126A to a plane 130 aligned along theproximal edge 126B of the lens. Thislens 126 refractslight rays focal point 134. - In contrast,
FIG. 9B illustrates anatraumatic lens 136 where the disc-shapedvoid space 138 has a thickness (t') measure fromsurface 136A to a plane 140 aligned along theproximal edge 136B of the lens. This lens, which has a hemispherical- or parabolic-shaped exterior surface and is made of similar materials as previously described forlens 46, refractslight rays focal point 142. With the thickness t of thevoid space 128 oflens 126 being greater than the thickness t' of thevoid space 138 of lens 136 (t > t'), it is shown that thefocal point 142 oflens 136 has shifted proximally along the longitudinal axis A-A in comparison to thefocal point 134 oflens 126 by distance (z). - Thus, as the lens thickness increases or the thickness of the disc-shaped void space decreases, the
light rays void space 96A oflens 47A shown inFIG. 7C will displace the focal point in a similar manner. -
Figure 10 illustrates another embodiment of an atraumatic head 14C according to the present disclosure. The atraumatic head 14C has an achromatic lens doublet that limits the effects of chromatic and spherical aberration and comprises adistal lens 144 optically connected to aproximal lens 146. The distal andproximal lens distal lens 144 is a negative (concave) lens made from flint glass such as F2, which has a relatively high dispersion that splits an incominglight ray 148 into itscomponent wavelengths proximal lens 146 is a positive (convex) lens made from crown glass such as BK7, which has a relatively lower dispersion. The chromatic aberration of thedistal lens 144 is essentially counterbalanced by that of theproximal lens 146. Theproximal lens 146 permits thecomponent wavelengths void space 150 where they are refracted to a commonfocal point 152 on the focal plane of the combined lens system where thecamera chip 16 is positioned (the focal plane is aligned along the forward or distal face of the chip 16). -
Figure 11 illustrates another embodiment of anatraumatic head 14D according to the present disclosure. Theatraumatic head 14D has ahousing 154 supporting anatraumatic lens 156.Lens 156 has a hemispherical- or parabolic-shaped exterior surface and is made of similar materials as previously described forlens 46. The housing comprises a cylindrically-shapedproximal section 154A meeting an enlarged diameter cylindrically-shapeddistal section 154B at anannular step 154C. The housingdistal section 154B has anannular rim 154D that surrounds arecess 158 leading to aninlet 160. A reduced diameter proximal portion of theatraumatic lens 156 is fitted into therecess 158 leading to theinlet 160 of thehousing 154. - An off-
set bore 162 extends through thehousing 154 from aproximal face 154E to theinlet 160. A printed circuit board (PCB) 54 resides in theinlet 158 to mechanically support thecamera chip 16, which is preferably a CMOS or CCD camera chip. The CMOS orCCD camera chip 16 is soldered onto or otherwise attached to thePCB 54 to mechanically fasten the two components together and electrically connect the camera chip to theelectrical cable 56. - The
electrical cable 56 extending along thegroove 58 in the core wire 44 (FIGs. 3 and4 ) electrically connects to thePCB 54 in thebore 162. Thecamera chip 16 is protected from damage by the transparentprotective coating 60. A prism-shapedmirror 164 is fitted into a proximal portion of theinlet 160. Then, a collimated gradient-index (GRIN)lens 166 having a parabolic variation of refractive index with radial distance from the longitudinal axis A-A (radial gradient of refractive index) is seated in a distal portion of theinlet 160 abutting an edge of the prism-shapedmirror 162. Themirror 164 is angles at 45° to the plane of the collimated image of theGRIN lens 166. The distalatraumatic lens 156 is made of a glass that causes exemplary incominglight rays focal point 174 inside thelens 156. This point is the distal focal point of theGRIN lens 166. The light rays 168, 170 and 172 disperse past thefocal point 174 as they enter theGRIN lens 166. -
Light ray 168 is shown entering thedistal lens 156 along the longitudinal axis A-A. Thislight ray 168 travels along that axis through theatraumatic lens 156, theGRIN lens 166 and a proximalvoid space 176 before impinging on themirror 164 which refracts the light ray 90° onto thecamera chip 16. -
Light ray 172 enters theatraumatic lens 156 spaced laterally above the longitudinal axis A-A to then refract through thefocal point 176 before entering theGRIN lens 166 where it bends through the radial refractive index of that lens to then enter the proximalvoid space 176 aligned substantially parallel to but spaced fromlight ray 168 traveling along the longitudinal axis A-A.Light ray 172 then impinges on themirror 164 to reflect 90° onto thecamera chip 16. -
Light ray 170 is shown entering theatraumatic lens 156 spaced from the longitudinal axis A-A and aligned betweenlight rays atraumatic lens 156 refracts thislight ray 170 through thefocal point 176 before it enters theGRIN lens 166 where the light ray bends through the gradient of refractive index of that lens to then enter the proximalvoid space 176 aligned substantially parallel to, but betweenlight rays Light ray 170 then impinges on themirror 164 where it is reflected 90° onto thecamera chip 16. -
Figure 12 illustrates another embodiment of anatraumatic head 14E according to the present disclosure. Theatraumatic head 14D has ahousing 154 supporting anatraumatic lens 156A.Lens 156A has a hemispherical- or parabolic-shaped exterior surface and is made of similar materials as previously described forlens 156. Further, the housing for theatraumatic head 14E is substantially the same as thehousing 154 for theatraumatic head 14D shown inFIG. 11 . However, theatraumatic lens 156A has a distal disc-shapedvoid space 178 so that exemplary incominglight rays focal point 180 inside thevoid space 178. Thispoint 180 is the distal focal point of theGRIN lens 166. The light rays 168, 170 and 172 then disperse past thefocal point 180 as they travel further through thedistal void space 178, theGRIN lens 166 and the proximalvoid space 176 before being reflected onto the camera chip byprism 164. -
Light ray 168 is shown entering thedistal lens 156A along the longitudinal axis A-A. Thislight ray 168 travels along that axis through theatraumatic lens 156A, thedistal void space 178, theGRIN lens 166 and the proximalvoid space 176 before impinging on themirror 164 which reflects the light ray 90° onto thecamera chip 16. -
Light ray 172 enters theatraumatic lens 156 spaced laterally above the longitudinal axis A-A to then refract through thefocal point 176 before entering theGRIN lens 166 where it bends through the radial refractive index of that lens to then enter the proximalvoid space 176 aligned substantially parallel to but spaced fromlight ray 168 traveling along the longitudinal axis A-A.Light ray 172 then impinges on themirror 164 to reflect 90° onto thecamera chip 16. -
Light ray 170 is shown entering theatraumatic lens 156 spaced from the longitudinal axis A-A and aligned betweenlight rays atraumatic lens 156 refracts thislight ray 170 through thefocal point 176 before it enters theGRIN lens 166 where the light ray bends through the gradient of refractive index of that lens to then enter the proximalvoid space 176 aligned substantially parallel to, but betweenlight rays Light ray 170 then impinges on themirror 164 where it is reflected 90° onto thecamera chip 16. - It is worth noting that according to Snell's Law, the angle of refraction α for
light ray 172 is greater than the angle of refraction γ forlight ray 170 in theatraumatic lens 156A. Similarly, the angle of refraction β oflight ray 172 is greater than the angle of refraction θ oflight ray 170 in the distal disc-shapedvoid space 178. Snell's law is a formula that is used to describe the relationship between the angles of incidence and refraction, when referring to light or other waves passing through a boundary between two different isotropic media, such as water, glass, or air. In optics, the law is used in ray tracing to compute the angles of incidence or refraction, and in experimental optics to find the refractive index of a material. Snell's law states that the ratio of the sines of the angles of incidence and refraction is equivalent to the ratio of phase velocities in the two media, or equivalent to the reciprocal of the ratio of the indices of refraction. -
Figure 13 illustrates an alternate embodiment of anatraumatic head 14F for theguidewire 10 shown inFIG. 1 . Thisatraumatic head 14F comprises a housing 182 connected to thedistal portion 44C of thecore wire 44. The housing 182 supports a distalatraumatic tip 184 that is not a lens but has a hemispherical- or parabolic-shaped exterior surface that helps prevent tissue damage as theguidewire 10 is advanced through thevasculature 42 of a patient. - The housing 182 comprises a cylindrically-shaped
proximal portion 182A meeting an enlarged diameter cylindrically-shapeddistal portion 182B at anannular step 182C. An annular taperedsidewall 182D leads to alateral inlet 185 which extends into thedistal portion 182B of the housing where the inlet meets an off-set bore 186. The off-set bore 186 leads to aproximal face 182E of the housing. The printed circuit board (PCB) 54 resides in the off-set bore 186 to mechanically support thecamera chip 16, which is preferably a CMOS or CCD camera chip, and electrically connect the camera chip to theelectrical cable 56. Atransparent coating 60 protects thecamera chip 16 from damage. - A
GRIN lens 188 resides in thelateral inlet 185 with itsinner face 188A aligned with the off-set bore 186. Anouter face 188B of theGRIN lens 188 supports a lateralatraumatic lens 190 which resides in theannular taper 182D. The lateralatraumatic lens 190 is made of a glass that causes exemplary incominglight rays focal point 198 inside thelateral lens 190. This point is the distal focal point of theGRIN lens 188. The light rays 192, 194 and 196 disperse past thefocal point 198 as they enter theGRIN lens 188. -
Light ray 192 is shown entering thelateral lens 190 along a longitudinal axis B-B. Thislight ray 192 travels along that axis through theatraumatic lens 190 and theGRIN lens 188 before impinging on the camera chip 16 (the focal plane is aligned along the forward or distal face of the chip 16). -
Light ray 196 enters theatraumatic lens 190 spaced from the longitudinal axis B-B to then refract through thefocal point 198 before entering theGRIN lens 188 where it bends through the radial refractive index of that lens to then align substantially parallel to but spaced fromlight ray 192 traveling along the longitudinal axis B-B.Light ray 196 then impinges on thecamera chip 16. -
Light ray 194 is shown entering theatraumatic lens 190 spaced from the longitudinal axis B-B and aligned betweenlight rays atraumatic lens 190 refracts thislight ray 194 through thefocal point 198 before it enters theGRIN lens 188 where the light ray bends through the gradient of refractive index of that lens to then align substantially parallel to, but betweenlight rays Light ray 194 then impinges on thecamera chip 16. -
Figure 14 illustrates an alternate embodiment of a hybridatraumatic head 14G for theguidewire 10 of the present disclosure shown inFIG. 1 . Thisatraumatic head 14G comprises ahousing 200 connected to thedistal portion 44C of thecore wire 44. Thehousing 200 supports a distalatraumatic lens 202, which has a hemispherical- or parabolic-shaped exterior surface and is made of similar materials as previously described forlens 46. Thehousing 200 comprises a cylindrically-shapedproximal section 200A meeting an enlarged diameter cylindrically-shapeddistal section 200B at an annular step 200C. The housingdistal section 200B has anannular rim 200D that surrounds arecess 204 leading to anaxial inlet 206. An off-set bore 208 extends through thehousing 200 from aproximal face 200E to theaxial inlet 206. A reduced diameter proximal portion of theatraumatic lens 202 is fitted into therecess 204 leading to theaxial inlet 206 to connect the hybridatraumatic head 14G to thehousing 200. - The
housing 200 also has an annulartapered sidewall 200F that leads to alateral inlet 210 which extends into thedistal section 200B of the housing. Thelateral inlet 210 meets theaxial inlet 206 with bothinlets set bore 208. The printed circuit board (PCB) 54 resides in the off-set bore 208 to mechanically support thecamera chip 16, which is preferably a CMOS or CCD camera chip, and electrically connect the camera chip to theelectrical cable 56. Atransparent coating 60 protects thecamera chip 16 from damage. - A prism-shaped
mirror 212 is fitted into a proximal portion of theaxial inlet 206. Then, an axially aligned collimated gradient-index (GRIN)lens 214 is seated in a distal portion of theaxial inlet 206 abutting an edge of the prism-shapedmirror 212. Themirror 212 is angles at 45° to the plane of the collimated image of theGRIN lens 214. The distalatraumatic lens 202 is made of a glass that causes exemplary incominglight rays focal point 222 inside thelens 202. This point is the distal focal point of theaxial GRIN lens 214. The light rays 216, 218 and 220 then disperse past thefocal point 222 as they enter theGRIN lens 214. -
Light ray 216 is shown entering the distalatraumatic lens 202 along the longitudinal axis A-A. Thislight ray 216 travels along that axis through theatraumatic lens 202, theaxial GRIN lens 214 and a proximalvoid space 216 before impinging on the prism-shapedmirror 212 which reflects the light ray 90° onto a distal portion of thecamera chip 16. -
Light ray 220 enters theatraumatic lens 202 spaced from the longitudinal axis A-A to then refract through thefocal point 222 before entering theaxial GRIN lens 214 where it bends through the radial refractive index of that lens to then enter the proximalvoid space 216 aligned substantially parallel to but spaced fromlight ray 216 traveling along the longitudinal axis A-A.Light ray 220 then impinges on the prism-shapedmirror 212 to reflect 90° onto the distal portion of thecamera chip 16. -
Light ray 218 is shown entering theatraumatic lens 202 aligned along the longitudinal axis A-A and betweenlight rays atraumatic lens 202 refracts thislight ray 218 through thefocal point 222 before it enters theaxial GRIN lens 214 where the light ray bends through the gradient of refractive index of that lens to then enter the proximalvoid space 216 aligned substantially parallel to, but betweenlight rays Light ray 218 then impinges on the prism-shapedmirror 164 where it is reflected 90° onto a distal portion of thecamera chip 16. - A
lateral GRIN lens 224 resides in thelateral inlet 210 with itsinner face 224A aligned with the off-set bore 208. Anouter face 224B of thelateral GRIN lens 224 supports a lateralatraumatic lens 226 which resides in theannular taper 200F. - The lateral
atraumatic lens 226 has a hemispherical- or parabolic-shaped exterior surface and is made of similar materials as previously described forlens 46. The lateraltraumatic lens 226 causes exemplary incominglight rays focal point 234 inside thelateral lens 226. This point is the distal focal point of thelateral GRIN lens 224. The light rays 228, 230 and 232 disperse past thefocal point 234 as they enter theGRIN lens 224. -
Light ray 228 is shown entering thelateral lens 226 along a longitudinal axis B-B. Thislight ray 228 travels along that axis through theatraumatic lens 226 and thelateral GRIN lens 224 before impinging on a distal portion of thecamera chip 16. -
Light ray 232 enters the atraumatic lens 236 spaced from the longitudinal axis B-B to then refract through thefocal point 234 before entering thelateral GRIN lens 224 where it bends through the radial refractive index of that lens to then align substantially parallel to but spaced fromlight ray 228 traveling along the longitudinal axis B-B.Light ray 232 then impinges on the distal portion of thecamera chip 16. -
Light ray 230 is shown entering theatraumatic lens 226 aligned along the longitudinal axis B-B and betweenlight rays atraumatic lens 226 refracts thislight ray 230 through thefocal point 234 before it enters thelateral GRIN lens 224 where the light ray bends through the gradient of refractive index of that lens to then align substantially parallel to, but betweenlight rays Light ray 194 then impinges on the distal portion of thecamera chip 16. -
Figure 15 is a schematic view of thecatheter 24 shown inFIGs. 1 and2 . As previously described, the cylindrically-shapedsidewall 26 of thecatheter 24 defines an axially-extendingprimary lumen 28 and supports a plurality of optical fibers, for example optical fibers 30, 32 and 34. The optical fibers 30, 32 and 34 are evenly spaced about theprimary lumen 28 and extend to respective light-emittinglenses vasculature 42 of a patient as the guidewire andcatheter system 10 of the present disclosure is used in a medical procedure. Preferably, thecatheter 24 is formed of a biocompatible and biostable primary polymeric material. Suitable materials include thermoplastics such as Nylon, PEBAX®, PET, thermosets such as silicone, polytetrafluoroethylene (PTFE), polyimide and composites such as liquid crystal polymers. If desired, these materials can be glass-filled or filled with a radiopaque material. Examples of radiopaque fillers are barium sulphate, bismuth subcarbonate, and tungsten. - In addition to the axially-extending
primary lumen 28, which is sized to receive theguidewire 12 during a medical procedure, thecatheter 24 also has several secondary lumens. Afirst wing 26A connected to thesidewall 26 provides anauxiliary lumen 240 that is used for any one of many purposes including providing saline, medicine or a secondary medical instrument to the body tissue of interest. Asecond wing 26B connected to thesidewall 26 provides aninflation lumen 242 that is used to inflate aballoon 244 secured to the catheter 24 a short distance proximal a distal end of the catheter. - A further embodiment of the
catheter 24 include push-pull wires extending from a handle assembly connected to a proximal end of the catheter to a distal end thereof. Manipulation of the handle assembly moves the push-pull wires to selectively deflect the distal end of the catheter. - During a medical procedure, the
guidewire 12 is inserted into the vasculature 42 (FIG. 1 ) of a patient through an incision into an accessible artery, such as the femoral artery. Thecatheter 24 is then moved over theguidewire 12 by aligning theprimary lumen 28 with the guidewire. Then, theguidewire 12 is connected to theproximal connector 18 so that thecontroller 20 can send electrical power to thecamera chip 16 in theatraumatic head 14. The light-emittinglens catheter 24 are used to visualize the path the guidewire is taking through thevasculature 42 before the surgeon begins studying a specific area of interest. In a preferred embodiment, each optical fiber 30, 32 and 34 in connected to a different wavelength spectrum coming from thecontroller 20 to allow multispectral illumination by the respective light-emittinglenses balloon 244 with saline throughlumen 242 and by flowing a saline solution throughauxiliary lumen 240 into the vessel and around the tissue under inspection. - Once powered, the
camera chip 16 is configured to send a video feedback to thecontroller 20 electrically connected to thedisplay 22 to show the surgeon the vasculature tissue immediately adjacent to the atraumatic head. The inverted image from thecamera chip 16 is converted to a visual image oriented to the surgeon's perspective of the tissue. Also, thecontroller 20 is programmed to process the image feedback from the camera chip to provide an in-vivo hyperspectral image (HSI) for disease diagnosis of the tissue of interest and image-guided surgery. HSI acquires a three-dimensional data set called a hypercube with two spatial dimensions (the image) and one spectral dimension (the light wavelength). - Moreover, the
controller 20 is programmed to cause the optical fibers 30, 32 and 34 optically connected light-emittinglenses camera chip 16 in a single exposure and thecontroller 20 then steps through the wavelengths to complete the data set. - In that respect, light delivered to biological tissue undergoes multiple scatterings because of the inhomogeneity of biological structures and absorption primarily in haemoglobin, melanin, and water as the light propagates through the tissue. The absorption, fluorescence, and scattering characteristics of tissue change during the progression of a disease. Therefore, the reflected, fluorescent, and transmitted light from tissue in the form of a hyperspectral image carries quantitative diagnostic information about tissue pathology. For example, vulnerable plaques constitute a risk for serious heart problems, and are difficult to identify using existing methods. Hyperspectral imaging combines spectral- and spatial information to provide a precise optical characterization of atherosclerotic lesions.
- Thus, the various forward viewing atraumatic heads described herein above, namely atraumatic head 14 (
FIGs. 7 ),atraumatic head 14A (FIG. 7B ),atraumatic head 14B (FIG. 7C ), atraumatic head 14C (FIG. 10 ),atraumatic head 14D (FIG. 11 ) andatraumatic head 14E (FIG. 12 ) provide the surgeon with a real-time hyperspectral image of the vasculature as the medical procedure, such as placing a stent or other medical device inside the body, is being done. Additionally, the side viewingatraumatic head 14 shown inFIG. 13 provides the surgeon with a real-time hyperspectral image of the sidewall of the vasculature somewhat proximal the atraumatic head, if that is desired. Further, if desired, the hybridatraumatic head 14G shown inFIG. 14 provides the surgeon with both a forward-looking hyperspectral image and a sidewall hyperspectral image of the vasculature during the medical procedure. - Once the medical procedure is completed, the saline solution is withdrawn from the
saline lumen 242 to deflate theballoon 244. The light-emittinglenses catheter system 10 is withdrawn from the vasculature. Theguidewire 12 is then disconnected from theproximal connector 18 for disposal or possible cleaning for re-use. Thecatheter 24 andconnector 18 can also be disposed of or cleaned for re-use. Thecontroller 20 anddisplay 22 can be used for many surgical procedures. - It is appreciated that various modifications to the inventive concepts described herein may be apparent to those skilled in the art without departing from the scope of the present invention as defined by the hereinafter appended claims.
Claims (15)
- A guidewire, comprising:a) a core wire extending along a longitudinal axis from a core wire proximal end to a core wire distal portion having a core wire distal end;b) a housing connected to the core wire distal end;c) a printed circuit board (PCB) electrically connected to a camera chip, wherein the PCB is connected to the housing;d) a power cable extending along the core wire to the PCB to thereby provide electrical power to the camera chip; ande) an atraumatic lens supported by the housing, wherein the camera chip resides between the atraumatic lens and the housing so that light rays entering the atraumatic lens are refracted to a focal plane aligned along a distal face of the camera chip.
- The guidewire of claim 1, wherein the atraumatic lens has a hemispherical- or parabolic-shaped exterior surface.
- The guidewire of claim 1 or 2, wherein the atraumatic lens is made from an optical glass selected from the group of silicon dioxide, fused silica and quartz, zinc selenide, zinc sulfide, germanium, sapphire, calcium fluoride, and barium fluoride, or the atraumatic lens is made from an optical plastic selected from the group of silicone elastomers, poly methyl methacrylate, polycarbonate, and polystyrene.
- The guidewire of any of claims 1 to 3, the focal plane aligned along the distal face of the camera chip is oriented perpendicular to the longitudinal axis of the core wire, and wherein the atraumatic lens has a proximally-facing hemispherical-, parabolic- or disc-shaped void space facing the camera chip so that light rays refracted by the atraumatic lens are further refracted by the void space before impinging on the focal plane aligned along the distal face of the camera chip.
- The guidewire of any of claims 1 to 4, wherein the atraumatic lens is optically connected to a proximal lens, and wherein the camera chip is axially aligned between the proximal lens and the housing.
- The guidewire of claim 5, wherein the atraumatic lens is a negative (concave) lens made from flint glass and the proximal lens is a positive (convex) lens made from crown glass, and wherein a light ray entering the atraumatic lens is refracted into its component wavelengths which are further refracted by the proximal lens and then refracted again by the void space to converge at a common focal point on the focal plane aligned along the distal face of the camera chip.
- The guidewire of claim 5, wherein the proximal lens is a collimating gradient-index (GRIN) lens and the housing supports a prism that resides between the GRIN lens and the camera chip, and wherein light rays refracted by the atraumatic lens are further refracted by the GRIN lens and then reflected by the prism to impinge on the camera chip.
- The guidewire of claim 7, wherein the atraumatic lens has a proximally-facing hemispherical-, parabolic- or disc-shaped void space facing the collimating GRIN lens.
- The guidewire of any of claims 1 to 8, wherein the housing has a distally facing recess, and wherein the PCB and camera chip are nested in the housing recess.
- The guidewire of any of claims 1 to 9, wherein the core wire has a distal tapered portion extending to the distal portion having the distal end, and wherein a coil spring connects between the distal tapered portion of the core wire and the housing.
- The guidewire of any of claims 1 to 10, wherein a protective coating resides between the atraumatic lens and the camera chip.
- The guidewire of any of claims 1 to 11, further comprising:a) an axially aligned collimated GRIN lens optically connected to the atraumatic lens;b) a prism residing between the axially aligned GRIN lens and the camera chip;c) a lateral atraumatic lens supported by the housing in a lateral inlet extending into the housing; andd) a lateral collimating GRIN lens supported by the housing and residing between the lateral atraumatic lens and the camera chip,e) wherein axially incoming light rays refracted by the atraumatic lens are further refracted by the axially aligned GRIN lens and then reflected by the prism to impinge on a distal portion of the camera chip, andf) wherein laterally incoming light rays refracted by the lateral atraumatic lens are further refracted by the lateral GRIN lens before impinging on a proximal portion of the camera chip.
- A guidewire, comprising:a) a core wire extending along a longitudinal axis from a core wire proximal end to a core wire distal portion having a core wire distal end;b) a housing connected to the core wire distal end, wherein the housing has a lateral inlet extending to an axial bore;c) a printed circuit board (PCB) electrically connected to a camera chip, wherein the camera chip and PCB reside in the axial bore of the housing with a focal plane of the cameral chip aligned parallel to the longitudinal axis of the core wire;d) a power cable extending along the core wire to the PCB to thereby provide electrical power to the camera chip;e) a distal atraumatic lens supported by the housing, wherein the distal atraumatic lens is optically connected to an axially aligned collimated gradient-index (GRIN) lens;f) a prism residing between the axially aligned GRIN lens and the camera chip;g) a lateral atraumatic lens supported by the housing in the lateral inlet; andh) a lateral collimating GRIN lens supported by the housing and residing between the lateral atraumatic lens and the camera chip,i) wherein axially incoming light rays refracted by the distal atraumatic lens are further refracted by the axially aligned GRIN lens and then reflected by the prism to impinge on a distal portion of the camera chip, andj) wherein laterally incoming light rays refracted by the lateral atraumatic lens are further refracted by the lateral GRIN lens before impinging on a proximal portion of the camera chip.
- The guidewire of claim 13, wherein the distal and lateral atraumatic lens each have a hemispherical- or parabolic-shaped exterior surface, or
wherein the distal and lateral atraumatic lens are individually made from an optical glass selected from the group of silicon dioxide, fused silica and quartz, zinc selenide, zinc sulfide, germanium, sapphire, calcium fluoride, and barium fluoride, or the atraumatic lens is made from an optical plastic selected from the group of silicone elastomers, poly methyl methacrylate, polycarbonate, and polystyrene. - The guidewire of claim 13 or 14, wherein the core wire has a distal tapered portion extending to the distal portion having the distal end, and wherein a coil spring connects between the distal tapered portion of the core wire and the housing.
Applications Claiming Priority (1)
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US201962939163P | 2019-11-22 | 2019-11-22 |
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EP3824793B1 true EP3824793B1 (en) | 2022-06-15 |
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EP20209203.7A Active EP3824793B1 (en) | 2019-11-22 | 2020-11-23 | Guidewire and catheter system for in-vivo forward viewing of the vasculature |
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EP (1) | EP3824793B1 (en) |
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JP3848062B2 (en) * | 2000-06-22 | 2006-11-22 | 三菱電機株式会社 | Imaging apparatus and mobile phone using the same |
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JP2003279862A (en) * | 2002-03-25 | 2003-10-02 | Machida Endscope Co Ltd | Omnidirectional endoscopic device |
JP2008532574A (en) * | 2005-01-27 | 2008-08-21 | スーパー ディメンション リミテッド | Endoscope with small imaging device |
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JP4674906B2 (en) * | 2006-07-03 | 2011-04-20 | オリンパス株式会社 | Optical system |
DE102006046555B4 (en) * | 2006-09-28 | 2010-12-16 | Grintech Gmbh | Miniaturized optical imaging system with high lateral and axial resolution |
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US20080214940A1 (en) * | 2007-03-02 | 2008-09-04 | Benaron David A | Medical imaging lens system, and method with high-efficiency light collection and collinear illumination |
JP2010522585A (en) * | 2007-03-22 | 2010-07-08 | マッケ カーディオバスキュラー エルエルシー | Method and apparatus for observing anatomical structures |
US10206821B2 (en) * | 2007-12-20 | 2019-02-19 | Acclarent, Inc. | Eustachian tube dilation balloon with ventilation path |
US20100081873A1 (en) * | 2008-09-30 | 2010-04-01 | AiHeart Medical Technologies, Inc. | Systems and methods for optical viewing and therapeutic intervention in blood vessels |
JP5814287B2 (en) * | 2013-03-25 | 2015-11-17 | 株式会社フジクラ | Guide wire |
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JP2018510025A (en) * | 2015-03-31 | 2018-04-12 | アクラレント インコーポレイテッドAcclarent, Inc. | Eustachian tube dilation balloon with ventilation path |
JPWO2016189731A1 (en) * | 2015-05-28 | 2018-04-19 | オリンパス株式会社 | Imaging apparatus and endoscope system |
DE102017107106A1 (en) * | 2017-04-03 | 2018-10-04 | Hoya Corporation | ENDOSCOPE WITH WIDE ANGLE OPTICS AND WORKING CHANNEL |
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JPWO2019111360A1 (en) * | 2017-12-06 | 2020-11-19 | オリンパス株式会社 | Endoscope |
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